Kornimate/medical-research-clean huggingface dataset:
measurements of zinc concentration on specimens taken during trans-perineal prostate biopsy

Conditions: Prostate Cancer

Summary: the purposes of this study are to: i) confirm and improve the accuracy of the correlation between levels of zinc in prostate tissue and the grade of prostate cancer in that tissue as determined through pathology; and ii) determine the levels of zinc in prostate tissue declared as non-cancerous by pathology and located in the vicinity of tissue declared as cancerous by pathology, and verify that the zinc levels for the declared non-cancerous tissue are lower (statistically significantly) than the levels for benign tissue not in the vicinity of cancerous tissue.


Eligibility criteria:
inclusion criteria: * elevated psa, \>10ng/ml * subject underwent primary and at least one secondary (repeat) prostate biopsy with negative diagnosis * subject directed at saturated trans-perineal biopsy exclusion criteria: * subject was under zn supplement nutrition treatment
premier: lifestyle interventions for blood pressure control

Conditions: Heart Diseases; Hypertension

Summary: to compare the effectiveness of advice versus two multicomponent lifestyle interventions to control blood pressure in participants with stage 1 hypertension or higher than optimal blood pressure.

background: a large body of data has been collected over the years documenting that on the one hand, reduced sodium intake, increased physical activity, weight loss, and moderate alcohol ingestion (comprehensive intervention) have been associated with a modest reduction of both systolic and diastolic blood pressure in with high normal and stage 1 hypertension. on the other hand, the dietary approaches to stop hypertension (dash) study has shown that a diet rich in fruits, vegetables, low-fat dairy products, and decreased saturated fat, total fat, and cholesterol (dash intervention) reduced both diastolic and systolic blood pressure in similar baseline blood pressure groups. design narrative: a multicenter study to determine the bp-lowering effects of two multi-component lifestyle intervention programs compared with advice only. eight hundred and ten men and women were randomly assigned to one of three treatment arms: (a) advice only; (b) comprehensive lifestyle intervention, in which participants received an intensive behavioral intervention program to facilitate achieving current lifestyle recommendations for bp control (reduced salt intake, increased physical activity, reduced alcohol intake, and weight control or weight loss if needed); and (c) comprehensive lifestyle intervention plus the dash diet, in which participants received a behavioral intervention program to promote the dash dietary pattern in addition to the same lifestyle recommendations for bp control. participants were followed for 18 months. the primary outcome variable was systolic blood pressure measured at six and 18 months after randomization. other variables included diastolic blood pressure, dietary adherence, physical activity, and onset of hypertension over the 18 months of follow-up. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.
a randomized controlled trial on the effect of needle gauge on the pain and anxiety experienced during arterial puncture

Conditions: Blood Gas Analysis; Pain

Summary: arterial blood-gas (abg) measurements are the gold standard to evaluate pulmonary gas exchange. however, arterial punctures are more painful than venous punctures and, in icu patients, cause greater anxiety than tracheal aspiration. the only technique that has been shown to effectively reduce pain during arterial punctures is the subcutaneous injection of lidocaine. however, this technique is more time consuming and is poorly used. topical anesthesia is widely used during arterial punctures despite the lack of proof of efficacy. while performing arterial punctures with small gauge needles is feasible, to the best of the investigators knowledge no studies have assessed the effect of needle gauge on arterial puncture related pain. the aim of the present study was to compare the pain experienced during arterial punctures performed with a 25 g or 23 g needle. the secondary endpoints were the characterization of the pain and the anxiety associated with the arterial punctures.


Eligibility criteria:
inclusion criteria: * patients who had a planned assessment of arterial blood gas in our respiratory department exclusion criteria: * under the age of 18 * inability to provide consent * the presence of a contraindication to arterial punctures based on the american association of respiratory care guidelines
genicular nerve radiofrequency ablation for chronic knee pain after total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: determine if genicular nerve radiofrequency ablation (rfa) is a clinically effective intervention for patients with chronic knee pain post-total knee arthroplasty (tka) as defined by pain.

more than 600,000 total knee arthroplasty (tka) surgeries are performed each year in the united states, and approximately 20% of patients will experience some element of chronic knee pain or dissatisfaction related to pain following this procedure. the options for management are limited, and physicians often resort to chronic opioid management. this creates a less than ideal situation for our elderly population who are more sensitive to the deleterious effects of opioids and who would greatly benefit from pain-free, independent mobility. the investigators propose a single-arm pilot study looking at performing fluoroscopically guided genicular nerve radiofrequency ablation (rfa) for patients with chronic (\>6 months) knee pain following a tka. a new paradigm for treating post-tka pain may be the use of rfa of the articular sensory nerve supply of the knee capsule, to desensitize the knee by blocking sensory afferents of the anterior capsule and thereby decreasing pain. while this modality has demonstrated efficacy for chronic knee pain due to osteoarthritis (oa) in the native knee, only one underpowered study has investigated this technique in chronic pain post-tka. further, this study targeted only three genicular nerves, while newer cadaveric studies have suggested multiple additional sensory nerves which if ablated may result in increased pain relief. a placebo-controlled explanatory trial of genicular nerve rfa for chronic pain post-tka of appropriate size and statistical methodology has not been conducted.

Eligibility criteria:
inclusion criteria: * age 30 to 90 years * at least one year post tka * have no indications for revision tka * ≥4/10 knee pain for \>6 months following tka * ≥80% relief with diagnostic genicular nerve blocks * willingness to undergo fluoroscopy-guided genicular nerve rfa treatment. exclusion criteria: * conditions that preclude rfa (e.g. pregnancy, pacemaker/icd, severe cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic. * inability to write, speak or read in english * patient refusal * significant psychiatric comorbidity

Keywords: genicular nerve radiofrequency ablation total knee arthroplasty chronic knee pain
ologen (oculusgen)-glaucoma and pterygium historical control study in beijing remin hospital

Conditions: Glaucoma; Pterygium

Summary: the purpose of this study is to determine whether the ologen (oculusgen) collagen matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

ologen (oculusgen) collagen matrix is a porous, scaffold matrix. it is to be implanted on the top of the scleral flap and beneath the conjunctiva and tenon's capsule at the end of trabeculectomy. the pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. the space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the iop in the right side. the collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (iop).

Eligibility criteria:
inclusion criteria: * age 18 years or over * patient able to cooperate with study procedures and able to perform tests reliably * patient willing to sign informed consent * patient able and willing to complete postoperative follow-up requirements * glaucoma：one/both eyes are affected by glaucoma * pterygium： patient with pterygium exclusion criteria: * known allergic reactions to collagen

Keywords: glaucoma pterygium collagen matrix oculusgen ologen trabeculectomy anti scarring prevent recurrence tissue engineering aeon astron
efficacy of diacerein supplementation on interleukin-1β, hs-crp, tnf-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients at dr. mohammad hoesin general hospital palembang

Conditions: Uncontrolled Diabetes; Diabetes Mellitus Type 2

Summary: the goal of this clinical trial is to learn if diacerein supplementation can help improve inflammation and glycemic control in adults with uncontrolled type 2 diabetes. it will also study the safety and tolerability of diacerein. the main questions it aims to answer are: * does diacerein lower levels of inflammatory markers like interleukin-1β, hs-crp, and tnf-α? * does diacerein improve blood sugar control? * what side effects or problems do participants have when taking diacerein? researchers will compare diacerein to a placebo (a look-alike substance with no active drug) to see if it works better for managing type 2 diabetes. participants will: * be adults aged 40-60 with uncontrolled type 2 diabetes * take either diacerein or a placebo every day for 12 weeks * visit the clinic for blood tests and monitoring at the beginning and end of the trial * be evaluated for side effects and medication adherence\]

the study aimed to evaluate the efficacy of diacerein supplementation compared to placebo towards interleukin-1β, hs-crp, tnf-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients. the current study was designed as a single-center double-blind randomized controlled clinical trial. the participants were voluntarily recruited 40-60 years old with uncontrolled type 2 diabetes mellitus. participants were randomized into two groups receiving diacerein add-on therapy or placebo. evaluations were conducted for side effects and adherence. towards interleukin-1β, hs-crp, tnf-α levels and glycemic control were evaluated at the beginning and at the end of the 12 weeks trial for analysis.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with uncontrolled type 2 diabetes mellitus who are receiving treatment at dr. mohammad hoesin general hospital, palembang. 2. male and female patients aged 40-59 years. 3. willing to participate in the study by signing the informed consent form. exclusion criteria 1. pregnant or breastfeeding. 2. history of allergy to medications containing rhein. 3. severe liver disorders. 4. chronic kidney disease. 5. malignancy. 6. currently receiving hormone replacement therapy. 7. autoimmune diseases. 8. severe bacterial infection. 9. osteoarthritis. 10. use of other anti-inflammatory drugs within the past 2 weeks. drop-out criteria 1. patients who discontinue medication for more than 2 weeks. 2. death. 3. occurrence of serious adverse drug reactions requiring discontinuation of the medication. 4. loss to follow-up.

Keywords: diacerein diabetes mellitus type 2 uncontrolled diabetes interleukin-1β hs-crp tnf-α
refraction determination analysis

Conditions: Myopia,; Hyperopia,; Astigmatism,; Presbyopia,; Eye Strain,

Summary: correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.


Eligibility criteria:
inclusion criteria: * 18-40 years old * healthy eyes exclusion criteria: * mid level ocular diseases (glaucoma, hypertension, retinal issues) * psychiatric disorders * brain tumor or history of * under 18, or over 40 years old
pharmacokinetic study on the addition of aprepitant to cisplatin - etoposide treatment in lung cancer patients

Conditions: Tumor

Summary: the purpose of this study is to determine whether aprepitant can be used in the cisplatin - etoposide chemotherapeutic regimen.

aprepitant acts initially as a moderate inhibitor of cyp3a4 followed by a short period of cyp3a4 induction. etoposide is a substrate of cyp3a4 and may therefore be suvject to a drug interaction with aprepitant. ce can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.

Eligibility criteria:
inclusion criteria: * between 18 and 75 years of age * able and willing to sign informed consent form * indication for treatment with ce regimen * subject is expected to receive at least 2 cycles of ce regimen * able to swallow capsules exclusion criteria: * history of sensitivity/idiosyncrasy to aprepitant or excipients * condition that might interfere with drug absorption, distribution metabolism or excretion. * history or current abuse of drugs, alcohol or solvents * inability to understand the nature and extent of the trial and procedures * participation in a drug trial within 30 days prior to the first dose * febrile illness within 3 days before the first dose * concomitant use of agents that are known to interfere with aprepitant pharmacokinetics * abnormal liver or renal function

Keywords: pharmacokinetics nausea and vomiting post chemotherapy
pk and pd study of natalizumab in pediatric subjects with rrms

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective of the study is to determine the pharmacokinetic (pk) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (rrms). the secondary objectives are as follows: to characterize the pharmacodynamic (pd) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.


Eligibility criteria:
key inclusion criteria: - rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain mri or a significant increase in t2 lesion load, as compared to a previous recent magnetic resonance imaging (mri) key exclusion criteria: * history of, or abnormal laboratory values indicative of, significant medical, neurologic (other than ms), or psychiatric disorders that might preclude participation in the study in the opinion of the investigator. * prior natalizumab therapy. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: pediatric
real-life-persistence to antifibrotic treatments

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this study will help to better understand the persistence rate to antifibrotic (af) treatment in real life in france and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to af treatment. primary objective of the study is to measure the percentage of patients still treated up to 30 months after af treatment initiation.


Eligibility criteria:
inclusion criteria: all patients with a reimbursement of af treatment between 2018 and 2022 will be included for analysis. exclusion criteria: no exclusion criteria will be applied.
resting energy expenditure evaluation in subjects with crohn's disease

Conditions: Crohn Disease

Summary: the aim of this study is to investigate the effect disease activity on resting energy expenditure (ree), body composition, inflammatory markers, food intake and quality of life in subjects affected by crohn's disease (cd)

malnutrition is a common sequel among patients affected by crohn's disease (cd). the pathogenic mechanisms include poor dietary intake, increased resting energy expenditure (ree), nutrient malabsorption and loss. so far, few studies have been carried out in cd adult patients, assessing the effect of disease activity on both ree and body composition. vaisman et al (2006) studied sixteen cd patients in remission (\> 3 mo) and showed no effect of ree on lower bmi, although in the presence of similar energy intake in according with previous studies (al-jaouni et al., 2000; schneeweiss et al., 1999). while, gong et al., 2015 found that patients with active disease had an increase in ree compared to patients in remission as already shown by rigaud et al., 1993; kushner and schoeller, 1991. overall, the effect of disease activity on ree is still uncertain and requires further investigation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of crohn's disease exclusion criteria: * comorbidity affecting energy metabolism (diabetes mellitus, thyroid dysfunction, etc.) * history of acute or chronic liver or kidney disease * current parenteral nutrition * presence of fistulae, ileostomy or colostomy * presence of extensive small bowel resection (residual small bowel \< 2 meters) * pregnancy or lactation

Keywords: energy expenditure body composition food intake
a study to evaluate bms-986278 in participants with normal renal function, severe renal impairment, or end-stage renal disease on intermittent hemodialysis

Conditions: Kidney Failure, Chronic; Healthy Volunteers; Renal Impairment

Summary: the purpose of this study is to assess the effect of severe renal impairment (ri) and end-stage renal disease (esrd) with intermittent hemodialysis (ihd) on the pharmacokinetics and safety of bms-986278. this study plans to use a staged design based on ri severity.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. note: for esrd participants, this body weight should be the prescription dry weight. * severe renal impaired participants: 1. participant has a supine sbp ≥ 90 and ≤ 180 mmhg, supine dbp ≥ 60 and ≤ 100 mmhg, and heart rate ≥ 40 and ≤ 110 beats per minute. 2. participant has severe ri as defined by an egfr ˂ 30 ml/min and not requiring dialysis at screening. 3. participant must be medically stable for at least 1 month before study intervention administration. * participants with esrd: 1. participant has esrd as defined by an egfr \< 15 ml/min at screening. 2. participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening. 3. participant has demonstrated adequate hemodialysis measurements (at least 2 kt/v measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening. * healthy participant should have a supine sbp ≥ 90 and ≤ 160 mm hg, supine dbp ≥ 50 and ≤ 100 mm hg, and heart rate ≥ 40 and ≤ 100 beats per minute. * healthy participants should have normal renal function, as defined by having an egfr ≥ 90 ml/min egfr at screening (calculated using the ckd-epi equation). exclusion criteria: * participant with any significant medical condition, laboratory abnormality, or psychiatric illness. * any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy). * individuals who are of childbearing potential, breastfeeding, or currently pregnant. * other protocol defined inclusion/exclusion criteria apply.
polyphenol metabotypes in people with diabetes type 2

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with t2dm in comparison to age-matched individuals without diabetes. additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).


Eligibility criteria:
inclusion criteria: * all participants * between 40-85 years * age-matched individuals without diabetes * bmi between 18.5-30 * no metabolic syndrome * persons with t2dm * at leats 2 years of clinical diagnoses of t2dm * stable medication use for at least 1 month exclusion criteria: * pregnancy of breastfeeding * in last month * acute use of anti/pre/probiotics * start of new drug or dietary supplements * major changes in diet * major lifestyle changes * diseases * gastrointestinal diseases (inflammatory bowel disease) * bariatric surgery * other forms of diabetes (cystic fibrosis/mody/t1dm) * heart problems (nyha 3/4) or previous cardiovascular events * liver problems: non-alcohol steatohepatitis (nash) and cirrhosis * lung problems (copd - gold 3/4), cystic fibrosis * uncontrolled thyroid function disruption in the past 6 months * intake of coumarin derivatives and direct oral anticoagulant medication * anti-cancer treatment: chemo-/immunotherapy * immonosuppressants (transplant) * antiepileptic drugs

Keywords: polyphenol transit time
discarded materials study

Conditions: Infertility

Summary: use of discarded embryos to advance laboratory expertise and technology in the area of human embryo development and assisted reproductive technologies

1- testing methods or freezing before implementing techniques. 2- develop cell surgery and micromanipulation techniques. 3- develop methods to optimize the determinations of genes and chromosomes 4- quality-assess laboratory equipment. 5- test proficiency of laboratory staff. 6- analyze what effects the early development of embryos. 7- develop new methods and media to allow for higher survival rates of embryos. 8- develop non-invasive tests for predicting embryo quality to predict ivf success.

Eligibility criteria:
inclusion criteria: none exclusion criteria: none

Keywords: ivf
post marketing surveillance for adacel™ in south korea

Conditions: Diphtheria; Tetanus; Pertussis

Summary: this safety surveillance study is being conducted in accordance with korea food and drug administration (kfda) notification no. 2009-46 "basic standard for reexamination of new drug". the study objective is to assess within 30 days post-administration, the safety of adacel™ administered under the real clinical practice.


Eligibility criteria:
inclusion criteria : * subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis. * written informed consent obtained from the subject. for subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -lar) of the subject. exclusion criteria : * none

Keywords: adacel diphtheria tetanus pertussis